Dawn Diode Laser System

K232885 · Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd · NVK · Feb 28, 2024 · General, Plastic Surgery

Device Facts

Record IDK232885
Device NameDawn Diode Laser System
ApplicantShanghai Wonderful Opto-Electrics Tech.Co.,Ltd
Product CodeNVK · General, Plastic Surgery
Decision DateFeb 28, 2024
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.4810
Device ClassClass 2
AttributesTherapeutic

Intended Use

450 nm, 635 nm and 980 nm Diode Laser: Intended for intra- and extra-oral surgery including incision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy. Whitening: Indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. Low Level Laser Therapy: Intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles. 810 nm Diode Laser in dentistry: Surgical applications requiring the ablation, vaporization, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology. Oral/Maxillofacial Indications; Incision, excision, vaporization, ablation and/or coagulation of soft tissue. Gingival troughing for crown impression; Gingivectomy; Gingivoplasty; Gingival incision and excision; Hemostasis and coagulation; Excisional and incisional biopsies; Fibroma removal; Frenectomy and frenotomy; Oral papillectomies; Soft tissue crown lengthening; Treatment of aphthous ulcers; Treatment of herpetic lesions. Periodontology; Laser soft tissue curettage; Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket. Cosmetic Dentistry; Laser-assisted bleaching/whitening of the teeth; Light activation for bleaching materials for teeth whitening; Implant recovery. 810 nm Diode Laser in therapy: Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle. 1064 nm Diode Laser in dentistry: Excisional and incisional biopsies; Excision and vaporization of herpes simplex I and II; Frenectomy and frenotomy; Gingivectomy; Gingivoplasty; Gingival incision and excision; Hemostasis; Implant recovery; Operculectomy; Pulpotomy and pulpotomy as an adjunct to root canal therapy; Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy; Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility); Treatment of aphthous ulcers and herpetic lesions.

Device Story

Dawn Diode Laser System is a surgical laser device using solid-state diodes (450nm, 635nm, 810nm, 980nm, 1064nm) to perform soft tissue procedures. Input energy is delivered via a flexible fiber optic cable to a handpiece; activation is controlled by a footswitch. The device is operated by clinicians in dental or surgical settings. The laser energy interacts with soft tissue to achieve surgical goals (incision, hemostasis, etc.) or provides thermal therapy for pain relief. The system includes a microcomputer control unit with a color touch screen interface for parameter adjustment. The device benefits patients by providing precise, minimally invasive soft tissue management and therapeutic pain relief.

Clinical Evidence

No clinical data was provided. Substantial equivalence was demonstrated through bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), and biocompatibility (ISO 10993).

Technological Characteristics

Solid-state diode laser; wavelengths 450/635/810/980/1064 nm; fiber optic delivery; stainless steel handpiece; color touch screen interface; wireless footswitch; software-controlled parameters; non-sterile delivery; biocompatible materials per ISO 10993.

Indications for Use

Indicated for patients requiring soft tissue surgical procedures (incision, excision, ablation, coagulation, hemostasis, vaporization) in dentistry, dermatology, and other surgical specialties; teeth whitening; and low-level laser therapy for temporary relief of minor muscle/joint pain, stiffness, arthritis, or muscle spasm and increased local blood circulation.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 28, 2024 Shanghai Wonderful Opto-Electrics Tech Co., Ltd. % Fu Ailing Consultant Aisnwei Information Technology Co., Ltd. 5F, Block 82, Zhangkeng 2nd Community, Minzhi Street, Longhua District Shenzhen, Guangdong 518109 CHINA Re: K232885 Trade/Device Name: Dawn Diode Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: NVK, ILY, GEX, EEG Dated: October 10, 2023 Received: October 16, 2023 Dear Fu Ailing: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of {1}------------------------------------------------ Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2}------------------------------------------------ Sincerely, ## Michael E. Adjodha -S Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K232885 ### Device Name Dawn Diode Laser System ### Indications for Use (Describe) 450 nm, 635 nm and 980 nm Diode Laser: · Intended for intra- and extra-oral surgery including incision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tıssue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy. ### Whitening: • Indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. Low Level Laser Therapy: · Intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles. ### 810 nm Diode Laser in dentistry: · Surgical applications requiring the ablation, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, ophthalmology, and pulmonology · Oral/Maxillofacial Indications; Incision, excision, vaporization, ablation and/or coagulation of soft tissue - · Gingival troughing for crown impression - · Gingivectomy - · Gingivoplasty - · Gingival incision and excision - · Hemostasis and coagulation - · Excisional and incisional biopsies - · Fibroma removal - · Frenectomy and frenotomy - · Oral papillectomies - · Soft tissue crown lengthening - · Treatment of aphthous ulcers - · Treatment of herpetic lesions - · Periodontology; - · Laser soft tissue curettage - · Laser soft tissue curettage - · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket {4}------------------------------------------------ - · Cosmetic Dentistry; - · Laser-assisted bleaching/whitening of the teeth - · Light activation for bleaching materials for teeth whitening - · Implant recovery 810 nm Diode Laser in therapy: · Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle. 1064 nm Diode Laser in dentistry: - · Excisional and incisional biopsies; - · Excision and vaporization of herpes simplex I and II; - · Frenectomy and frenotomy; - · Gingivectomy; - · Gingivoplasty; - · Gingival incision and excision; - · Hemostasis; - · Implant recovery; - · Operculectomy; - · Pulpotomy and pulpotomy as an adjunct to root canal therapy; - · Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy; · Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility): · Treatment of aphthous ulcers and herpetic lesions Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.qov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ ### 510(k) Summary-K232885 This summary of 510(K) safety and effectiveness is submitted according to requirements of SMDA and 21 CFR §807.92. ### 5.1 Administrative Information | Date of Summary prepared | May 27, 2023 | |-----------------------------------|---------------------------------------------------------------------------------------------------------| | Manufacturer information | Submitter's Name: Shanghai Wonderful Opto-Electrics Tech Co., Ltd. | | | Address: 2F, Building 11, Lane 1175, Tongpu Rd., Putuo District, Shanghai, 200333 China | | | Contact person: Lily Zhou | | | Mobile phone: +86-13701883482 | | | Mail: laser@wonderful-sh.com | | Submission Correspondent | Company Name: Aisnwei Information Technology Co., Ltd. | | | Address: 5F, Block 82, Zhangkeng 2nd Community, Minzhi Street, Longhua District, Shenzhen, 518109 China | | | Contact person: Ms. Fu Ailing | | | Mobile phone: +86-13538216349 | | | E-Mail: fuailing@aisnwei.com | | Establishment registration number | 3004505220 | ### 5.2 Device Information | Type of 510(k) submission: | Traditional | |----------------------------|----------------------------------------------------------------------------------------| | Common Name: | Dawn Laser | | Trade Name: | Dawn Diode Laser System | | Model: | Dawn | | Classification name: | Laser Surgical Instrument For Use In General And Plastic<br>Surgery And In Dermatology | | Review Panel: | General & Plastic Surgery | | Primary Product Code: | NVK | | Secondary Product Codes | GEX, ILY | {6}------------------------------------------------ | Shanghai Wonderful | 510(k) Summary | |---------------------|-----------------| | Product: Dawn Laser | Version:A/1 | | | | | Device Class: | II | | Regulation Number: | 21 CFR 878.4810 | ### 5.3 Predicate Devices and Reference Devices | Predicate device | 510(k) number: K210367<br>Trade name: D-Laser Blue, D-Laser 16<br>Product code: NVK, ILY, GEX | |------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | | 510(k) number: K221712<br>Trade name: Fotona XPulse Laser System Family (XPulse<br>1064 nm, XPulse 810 nm, XPulse 980 nm<br>Product code: GEX | | Reference device | 510(k) number: K071687<br>Trade name: Family of IRIDEX® IQ Laser System (IQ532,<br>IQ577, IQ 630-670, IQ810)<br>Product code: GEX | | | 510(k) number: K163128<br>Trade name: Epic Pro<br>Product code: GEX | | | 510(k) number: K111643<br>Trade name: Opto Mitra Yellow Laser<br>Product code: GEX | | | 510(k) number: K202991<br>Trade name: Fotona XPulse Pro Laser Platform<br>Product code: GEX | | | 510(k) number: K222701<br>Trade name: MANTA Laser<br>Product code: GEX | ### 5.4 Device Description The Dawn Diode Laser System manufactured by SWOT LASERS is a surgical device at the cutting edge of technology, designed for a wide variety of soft tissue procedures. The Dawn Diode Laser System utilizes a solid state diode as laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of footswitch. {7}------------------------------------------------ Version:A/1 ### Product: Dawn Laser This laser instrument consists of fiber connecting diode laser system, power supply system and microcomputer control system. The Dawn Diode Laser System employs the diodes with wavelengths of 450nm, 635nm, 810nm, 980nm and 1064nm, and the device emits laser output energy in blue (450nm), red (635nm), orange (980nm) spectra respectively. ### 5.5 Intended Use/Indications for Use 450 nm, 635 nm and 980 nm Diode Laser: - Intended for intra- and extra-oral surgery including incision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and are indicated for: frenectomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy. Whitening: - Indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. Low Level Laser Therapy: - Intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain {8}------------------------------------------------ Version:A/1 and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles. 810 nm Diode Laser in dentistry: - Surgical applications requiring the ablation, vaporization, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolarynqology, ophthalmology, and pulmonology - Oral/Maxillofacial Indications; Incision, excision, vaporization, ablation and/or coagulation of soft tissue - Gingival troughing for crown impression - Gingivectomy - · Gingivoplasty - Gingival incision and excision - · Hemostasis and coagulation - Excisional and incisional biopsies - Fibroma removal - Frenectomy and frenotomy - Oral papillectomies - · Soft tissue crown lengthening - Treatment of aphthous ulcers - Treatment of herpetic lesions - · Periodontology; - Laser soft tissue curettage - Laser soft tissue curettage - · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket - Cosmetic Dentistry: - Laser-assisted bleaching/whitening of the teeth - Light activation for bleaching materials for teeth whitening - Implant recovery {9}------------------------------------------------ 810 nm Diode Laser in therapy: - · Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle. 1064 nm Diode Laser in dentistry: - Excisional and incisional biopsies: - · Excision and vaporization of herpes simplex I and II; - · Frenectomy and frenotomy; - · Gingivectomy; - · Gingivoplasty; - · Gingival incision and excision; - · Hemostasis; - Implant recovery; - · Operculectomy; - · Pulpotomy and pulpotomy as an adjunct to root canal therapy; - Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy; - Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss, and tooth mobility); - · Treatment of aphthous ulcers and herpetic lesions ### 5.6 Indications for Use and Technological Characteristics of the Subject Devices Compared to the Predicate Devices {10}------------------------------------------------ Product: Dawn Laser 003_510(k) Summary Version:A/1 # Table 1 Comparison Between the Indications for Use and Technological Characteristics of Dawn Diode Laser System | Proposed Device | Predicate Device 1 | Discussion of the differences between proposed device and predicate device | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | Shanghai Wonderful<br>Dawn Diode Laser System<br>(To be decided) | Guilin Woodpecker<br>D-Laser Blue<br>(K210367) | | | Product Code | | | | NVK, GEX, ILY | NVK, GEX, ILY | Same | | Regulation Number | | | | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | | Classification | | | | Class II | Class II | Same | | 450 nm, 635 nm and 980 nm Diode Laser Indication for Use | | | | • Intended for intra- and extra-oral surgery including incision,<br>excision, hemostasis, coagulation and vaporization of soft tissue<br>including marginal and inter-dental and epithelial lining of free<br>gingiva and are indicated for: frenectomy; frenotomy; biopsy;<br>operculectomy; implant recovery; gingivectomy; gingivoplasty;<br>gingival troughing; crown lengthening; hemostasis of donor site;<br>removal of granulation tissue; laser assisted flap surgery;<br>debridement of diseased epithelial lining; incisions and draining of<br>abscesses; tissue retraction for impressions; papillectomy; | D-Laser Blue and D-Laser 16 are Intended for intra- and extra-oral<br>surgery including incision, excision, hemostasis, coagulation and<br>vaporization of soft tissue including marginal and inter-dental and<br>epithelial lining of free gingiva and are indicated for: frenectomy;<br>frenotomy; biopsy; operculectomy; implant recovery; gingivectomy;<br>gingivoplasty; gingival troughing; crown lengthening; hemostasis of<br>donor site; removal of granulation tissue; laser assisted flap<br>surgery; debridement of diseased epithelial lining; incisions and<br>draining of abscesses; tissue retraction for impressions; | Same | {11}------------------------------------------------ Product: Dawn Laser 003_510(k) Summary Version:A/1 | vestibuloplasty; excision of lesions; exposure of | |----------------------------------------------------| | unerupted/partially erupted teeth; removal of hype | | treatment of aphthous ulcers; leukoplakia; laser r | | unerupted | unerupted/partially erupted teeth; removal of hyperplastic tissues; | |--------------|-----------------------------------------------------------------------| | treatment | treatment of aphthous ulcers; leukoplakia; laser removal of | | diseased, | diseased, infected, inflamed and necrosed soft tissue within the | | periodonta | periodontal pocket; sulcular debridement (removal of diseased, | | infected, in | infected, inflamed and necrosed soft tissue in the periodontal | | to improve | pocket to improve clinical indices including gingival index, gingival | | index, prob | bleeding index, probe depth, attachment loss and tooth inability); | | pulpotomy | pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma | | gingival inc | removal; gingival incision and excision; treatment of canker sores; | | ulcers of th | herpetic ulcers of the oral mucosa; laser soft tissue curettage; | | gingival hy | reduction of gingival hypertrophy. | ## Whitening: - whitening and for laser-assisted whitening/bleaching of tee Indicated for light activation for bleaching materials for # רן | Low Level Laser Therapy: | Low Level Laser Therapy: | |--------------------------------------------------------------------|--------------------------------------------------------------------| | Intended to emit energy in the red and infrared spectrum to | D-Laser Blue and D-Laser 16 are intended to emit energy in the | | provide topical heating for the purpose of elevating tissue | and infrared spectrum to provide topical heating for the purpose | | temperature for the temporary relief of minor muscle and joint | elevating tissue temperature for the temporary relief of minor | | pain and stiffness, minor arthritis pain, or muscle spasm, and for | muscle and joint pain and stiffness, minor arthritis pain, or musc | | the temporary increase in local blood circulation and/or temporary | spasm, and for the temporary increase in local blood circulation | | issues; | papillectomy; vestibuloplasty; excision of lesions; exposure of<br>unerupted/partially erupted teeth; removal of hyperplastic tissues; | |----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | the | treatment of aphthous ulcers; leukoplakia; laser removal of | | sed, | diseased, infected, inflamed and necrosed soft tissue within the | | sed | periodontal pocket; sulcular debridement (removal of diseased, | | tal | infected, inflamed and necrosed soft tissue in the periodontal pocket | | gingival | to improve clinical indices including gingival index, gingival bleeding<br>index, probe depth, attachment loss and tooth inability); pulpotomy; | | oma | pulpotomy as adjunct to root canal therapy; fibroma removal; | | sores; | gingival incision and excision; treatment of canker sores; herpetic | | e; | ulcers of the oral mucosa; laser soft tissue curettage; reduction of<br>gingival hypertrophy. | | | Whitening: | | ch. | D-Laser Blue and D-Laser 16 are indicated for light activation for<br>bleaching materials for teeth whitening and for laser-assisted<br>whitening/bleaching of teeth. | | | Low Level Laser Therapy: | | | D-Laser Blue and D-Laser 16 are intended to emit energy in the red<br>and infrared spectrum to provide topical heating for the purpose of | {12}------------------------------------------------ 003_510(k) Summary Product: Dawn Laser Version:A/1 | relaxation of muscles. | and/or temporary relaxation of muscles. | | | |---------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------| | Application | Dental Laser | Dental Laser | Same | | Laser Classification | | | | | 450 nm Laser: Class IV | 450 nm Laser: Class IV | Same | | | 635 nm Laser: Class II | 650 nm Laser: Class II | Different but acceptable as<br>Reference Device K071687: IQ 630-<br>670. | | | 980 nm Laser: Class IV | 976 nm Laser: Class IV | Different but same as Reference<br>Device K163128 : 980nm | | | Laser Type | | | | | Solid state diode | Solid state diode | Same | | | Laser Wavelength | | | | | 450 nm (+/-20 nm)<br>(430-470) | 450 nm (+/-20 nm)<br>(430-470) | Same | | | 635 nm (+/-20 nm)<br>(615-655) | 650 nm (+/-20 nm)<br>(630-670) | Different but same as Reference<br>Device K111643 : 635nm ((+/-20 nm)<br>or 615nm-655nm | | | 80 nm (+/-20 nm)<br>(960-1000) | 976 nm (+/-20 nm)<br>(956-996) | Different but same as Reference<br>Device K163128 : 980 nm (+/-20 nm<br>or 960-1000 nm | | | Optical Power | | | | | 450 nm:<br>1.1 W - 4 W (Continuous Wave) | 450 nm:<br>0.2 W - 3.0 W (Continuous Wave)<br>4 W (peak power) | Different but acceptable as<br>Reference Device K202291 : 445nm:<br>Up to 4W | | | 635 nm:<br>10 mW - 300 mW (Continuous Wave) | 650 nm:<br>25 mW - 200 mW (Continuous Wave) | Different but acceptable as<br>Reference Device K071687: IQ 630-<br>670: ≤ 5W | | | 980 nm:<br>1.1 W - 8 W (Continuous Wave) | 976 nm:<br>0.2 W - 4 W (Continuous Wave)<br>7 W (peak power) | Different but acceptable as<br>Reference Device K202291 : 980nm:<br>Up to 12W | | | Emission Modalities | | | | | Continuous Wave<br>Chopped (up to 20 kHz) | • Continuous Wave<br>• Chopped (1 Hz - 20 kHz) | Different but acceptable as<br>Reference Device K163128: Up to 20 kHz (20,000 Hz). | | | Pulse Duration | | | | | Chopped Mode:<br>10 µsec - 9.9 sec. | Chopped Mode:<br>5 µsec To 0.9 sec. | Different but acceptable as<br>Reference Device K163128 : 0.01-<br>100ms (10 µ sec-100ms) and<br>Reference Device K202991: 0.1ms-60s. | | | Aiming Beam | | | | {13}------------------------------------------------ 003_510(k) Summary Product: Dawn Laser Version:A/1 {14}------------------------------------------------ 003_510(k) Summary | 635±20 nm<br>Pmax<5 mW | 650±20 nm<br>Pmax<5 mW | Different but acceptable as<br>Reference Device K222701: Red<br>635-650 nm (<5 mW). | |------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Optical Fiber Surgical Tips | | | | Fiber Diameter:<br>200 μm, 400 μm | Fiber Diameter:<br>200 μm, 300 μm, 400 μm, | The fiber diameters of the subject<br>device are two of those of the<br>predicate device, so the difference<br>can be acceptable. | | • Single-use tips.<br>• Integral laser fiber.<br>• Plastic proximal connection hub.<br>• Bendable stainless steel cannula.<br>• Provided non-sterile | • Single-use tips.<br>• Integral laser fiber.<br>• Plastic proximal connection hub.<br>• Bendable stainless steel cannula.<br>• Provided non-sterile | Same | | Laser Handpiece | | | | • Handpiece connected by flexible optical fiber to control unit.<br>• Finger switch laser activation.<br>• Removable, sterilizable stainless steel outer sleeve. | • Handpiece connected by flexible optical fiber to control unit.<br>• Finger switch laser activation.<br>• Removable, sterilizable stainless steel outer sleeve. | Same | | Laser Therapy Light Guides | | | | N/A | N/A | Same | | Activation Method | | | | • Handpiece finger switch<br>• Wireless foot switch | • Handpiece finger switch<br>• Wireless foot switch | Same | {15}------------------------------------------------ Product: Dawn Lase 003_510(k) Summary Version:A/1 | Laser Control Unit Dimensions | | | |---------------------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------| | 200 mm x 200 mm x 180 mm | 190 mm x 180 mm x 200 mm | Due to different design scheme, the<br>difference does not raise any new<br>issue of substantial equivalence. | | Laser Control Unit User Interface | | | | Color touch screen graphical user interface | Color touch screen graphical user interface | Same | # Table 2 Comparison Between the Indications for Use and Technological Characteristics of Dawn Diode Laser System and those of the Predicate Device 2 | Proposed Device | Predicate Device 2 | Discussion of the<br>differences between<br>proposed device and<br>predicate device | |------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Shanghai Wonderful<br>Dawn Diode Laser System<br>(To be decided) | Fotona d.o.o<br>Fotona XPulse Laser System Family (XPulse 1064<br>nm, XPulse 810 nm, XPulse 980 nm)<br>(K221712) | | | Product Code | | | | NVK, GEX, ILY | GEX | Same | | Regulation Number | | | | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | | Classification | | | | Class II | Class II | Same | | 810 nm Diode Laser Indication for Use | | | {16}------------------------------------------------ Product: Dawn Laser Version:A/1 003_510(k) Summary | 810 nm Diode Laser in dentistry: | 810 nm Diode Laser in dentistry: | Same | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology Oral/Maxillofacial Indications; Incision, excision, vaporization, ablation and/or coagulation of soft tissue Gingival troughing for crown impression Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Excisional and incisional biopsies Fibroma removal Frenectomy and frenotomy Oral papillectomies Soft tissue crown lengthening Treatment of aphthous ulcers Treatment of herpetic lesions Periodontology; Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft Laser soft tissue curettage | Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology Oral/Maxillofacial Indications; Incision, excision, vaporization, ablation and/or coagulation of soft tissue Gingival troughing for crown impression Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Excisional and incisional biopsies Fibroma removal Frenectomy and frenotomy Oral papillectomies Soft tissue crown lengthening Treatment of aphthous ulcers Treatment of herpetic lesions Periodontology; Laser soft tissue curettage Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft | | {17}------------------------------------------------ 003_510(k) Summary | 1 | | |---|---| | - | | | | | | C | | | | œ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | > | | | | | | | | | | | | | | | | | | | | | | | | | | tissue within the periodontal pocket<br>• Cosmetic Dentistry;<br>• Laser-assisted bleaching/whitening of the teeth<br>• Light activation for bleaching materials for teeth whitening<br>• Implant recovery | 810 nm Diode Laser in therapy:<br>• Temporary relief of minor muscle and joint pain and stiffness,<br>minor arthritis pain, or muscle spasm, minor sprains and<br>strains, and minor muscular back pain; the temporary increase in<br>local blood circulation; the temporary relaxation of muscle. | Similar, and same as the Predicate<br>Device K210367: D-Laser Blue | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------| | tissue within the periodontal pocket<br>• Cosmetic Dentistry;<br>• Laser-assisted bleaching/whitening of the teeth<br>• Light activation for bleaching materials for teeth whitening<br>• Implant recovery | 980 nm Diode Laser Indication for Use<br>• Intended for intra- and extra-oral surgery including incision,<br>excision, hemostasis, coagulation and vaporization of soft tissue<br>including marginal and inter-dental and epithelial lining of free<br>gingiva and are indicated for: frenectomy; frenotomy; biopsy;<br>operculectomy; implant recovery; gingivectomy; gingivoplasty;<br>gingival troughing; crown lengthening; hemostasis of donor site;<br>removal of granulation tissue; laser assisted flap surgery;<br>debridement of diseased epithelial lining; incisions and draining of<br>abscesses; tissue retraction for impressions; papillectomy;<br>vestibuloplasty; excision of lesions; exposure of unerupted/partially<br>erupted tooth: removal of hyperplastic tissues: treatment of | | | | 980 nm Diode Laser in dentistry:<br>• Surgical applications requiring the ablation, vaporization,<br>excision, incision, hemostasis, or coagulation of soft tissues in<br>medical specialties including dermatology, dentistry,<br>gastroenterology, general surgery, genitourinary, gynecology,<br>neurosurgery, otolaryngology, orthopedics, ophthalmology,<br>pulmonology and thoracic surgery<br>• Gingival troughing<br>• Crown lengthening<br>• Gingivoplasty<br>• Coagulation | | {18}------------------------------------------------ Product: Dawn Laser 003_510(k) Summary Version:A/1 | aphthous ulcers; leukoplakia; laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy. | Implant uncovery Implant recovery Soft tissue curettage Sulcular debridement Biopsy Frenectomy Hemostasis of donor site Operculectomy Exposure of unerupted teeth Pulpotomy Treatment of aphthous ulcers Excision of lesions Light activation of bleaching materials for teeth whitening | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Whitening:<br>• Indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. | | | Low Level Laser Therapy:<br>• Intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles. | | {19}------------------------------------------------ Product: Dawn Laser Version:A/1 003_510(k) Summary | 1064 nm Diode Laser in dentistry:<br>• Excisional and incisional biopsies;<br>• Excision and vaporization of herpes simplex I and II;<br>• Frenectomy and frenotomy;<br>• Gingivectomy;<br>• Gingivoplasty;<br>• Gingival incision and excision;<br>• Hemostasis;<br>• Implant recovery;<br>• Operculectomy;<br>• Pulpotomy and pulpotomy as an adjunct to root canal therapy;<br>• Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy;<br>• Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility);<br>• Treatment of aphthous ulcers and herpetic lesions | 1064 nm Diode Laser in dentistry:<br>• Excisional and incisional biopsies;<br>• Excision and vaporization of herpes simplex I and II;<br>• Frenectomy and frenotomy;<br>• Gingivectomy;<br>• Gingivoplasty;<br>• Gingival incision and excision;<br>• Hemostasis;<br>• Implant recovery;<br>• Operculectomy;<br>• Pulpotomy and pulpotomy as an adjunct to root canal therapy;<br>• Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy;<br>• Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility);<br>• Treatment of aphthous ulcers and herpetic lesions | Same | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | | 1064 nm Diode Laser in dermatology and other surgical areas:<br>• General surgery indications: surgical incision, excision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs | | {20}------------------------------------------------ Product: Dawn Laser 003_510(k) Summary Version:A/1 | and glands, fibroma removal;<br>• Podiatry (ablation, vaporization, incision, excision, and coagulation<br>of soft tissue) including: Matrixectomy, Periungual and subungual<br>warts, Plantar warts, Radical nail excision, Neuromas.<br>• Temporary increase of clear nail in patients with onychomycosis<br>(e.g. dermatophytes Trichophyton rubrum and T mentagrophytes<br>and/or yeasts Candida albicans, etc.);<br>1064 nm Diode Laser in therapy<br>• Temporary relief of muscle and joint pain and stiffness, arthritis<br>pain or muscle spasm, temporary increase in local blood<br>circulation and/or promoting relaxation of muscle. | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|------------------------------------------------------| | Engergy source | | | | Solid State Diode | Solid State Diode | Same | | Wavelength | | | | 810 nm | 810 nm | Same | | 980 nm | 980 nm | Same | | 1064 nm…
Innolitics
510(k) Summary
Decision Summary
Classification Order
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